MediciNova Provides Shareholder Update on Key Developments

Rhea-AI Summary

MediciNova (NASDAQ: MNOV) announced two significant developments. First, the company secured a Standby Equity Purchase Agreement (SEPA) worth up to $30 million over 36 months, with shares priced at 97% of market value. The SEPA proceeds will support R&D programs and corporate activities.

Second, MediciNova achieved its target enrollment in the COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast). The company is also running an Expanded Access Program supported by a $22 million NIH grant. Additionally, patient enrollment is nearly complete for their Phase 2 trial of MN-001 in hypertriglyceridemia and fatty liver disease.

Positive

• Secured up to $30 million in flexible equity financing through SEPA
• Achieved target enrollment in COMBAT-ALS Phase 2b/3 trial
• Received $22 million NIH grant for Expanded Access Program
• Near completion of Phase 2 trial enrollment for MN-001

Negative

• SEPA agreement includes 3% discount to market price on share sales
• Potential dilution risk from future equity issuance through SEPA

Insights

Biotechnology Investment Analyst

MediciNova secured $30M financing flexibility while hitting key enrollment milestones in ALS trials, strengthening their clinical and financial position.

MediciNova has made two significant advances that strengthen both their financial flexibility and clinical development pipeline. The company secured a $30 million Standby Equity Purchase Agreement (SEPA) that provides an on-demand capital option over the next 36 months. This financial instrument allows MediciNova to sell shares at 97% of market price without issuing additional warrants - a relatively favorable arrangement compared to more dilutive financing alternatives typically available to clinical-stage biotechs.

More importantly from a clinical perspective, MediciNova has achieved target enrollment in its COMBAT-ALS Phase 2b/3 trial of MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis. This enrollment milestone is a critical inflection point that indicates the trial is progressing toward data readout. The company is simultaneously running a substantial Expanded Access Program supported by a $22 million NIH grant, suggesting institutional confidence in the program.

The company is also advancing MN-001 (Tipelukast) in a Phase 2 trial for hypertriglyceridemia and fatty liver disease associated with Type 2 diabetes, with enrollment nearing completion. This dual-pronged clinical strategy gives MediciNova multiple potential value-creating catalysts in the near to medium term.

Management's commentary indicates they believe their ALS program is among the most advanced in development, with encouraging data from two previous clinical trials. The capital raised through the SEPA agreement, if utilized, would support both ongoing R&D and potential strategic opportunities, giving the company operational runway and flexibility during this critical clinical development phase.

LA JOLLA, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the “Company”), provides a shareholder update recapping important developments for the Company.

Standby Equity Purchase Agreement (SEPA)

The Company reported the signing of a Standby Equity Purchase Agreement (SEPA) for up to $30 million worth of common stock over the course of 36 months. Under that Agreement, the Company shall have the right, but not the obligation, to sell its common stock in individual transactions – or advances – which will be up to 100% of the daily volume traded of MediciNova’s common stock during the five days immediately prior to the transaction date. The stock will be issued without additional warrants and will be sold to one or more investment funds managed by Yorkville Advisors – in this case the investor – at a purchase price equal to 97% of the market price¹. Proceeds from the transactions will be used to further advance R&D programs and for general corporate activities.

COMBAT-ALS Trial Patient Target Enrollment Achieved as Other Trials Continue

The Company recently announced the successful enrollment of the target number of participants in its COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast). MN-166 is currently in development for the treatment of Amyotrophic Lateral Sclerosis (ALS). In parallel, the Company is conducting a large Expanded Access Program (EAP) supported by a $22 million grant from the National Institutes of Health (NIH), which is steadily enrolling patients. The Company is also nearing completion of its Phase 2 clinical trial targeted patient enrollment in hypertriglyceridemia and fatty liver disease due to Type 2 diabetes with its second asset, MN-001 (Tipelukast).

Dr. Yuichi Iwaki, MediciNova President and CEO, commented, "These developments are essential to our continued thriving in the market. We have completed our target enrollment of our COMBAT-ALS trial for our lead compound, MN-166. This is a significant development for ALS and may provide hope for the hundreds of thousands of patients who are suffering from the condition. We believe that our trial is among the furthest along in the space, and data from two previous clinical trials have been encouraging. Our cash position continues to afford us ability to amply fund our ongoing programs, and this SEPA agreement provides us with additional flexibility if needed to access capital to further support our R&D initiatives, expand our business, and pursue strategic opportunities in an all equity transaction. We are encouraged by our ongoing progress and look forward to providing additional updates on both our main programs and our partnered non-core programs over the near term and in the coming months.”

About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Forward-Looking Statements
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166 and MN-001. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166 and MN-001, and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2024 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

INVESTOR CONTACT:

David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com

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¹ Market price is the lowest daily volume weighted average price (VWAP) of the common stock during the pricing period of three consecutive days commencing on the trading day immediately following the investor’s receipt of an Advance Notice.

FAQ

What is the value of MediciNova's (MNOV) new Standby Equity Purchase Agreement?

MediciNova secured a $30 million SEPA over 36 months, allowing them to sell shares at 97% of market price to funds managed by Yorkville Advisors.

What milestone did MNOV achieve in its COMBAT-ALS clinical trial?

MediciNova reached its target patient enrollment for the Phase 2b/3 COMBAT-ALS trial of MN-166 (ibudilast) for ALS treatment.

How much NIH funding did MediciNova receive for its ALS program?

MediciNova received a $22 million grant from the National Institutes of Health (NIH) to support its Expanded Access Program for ALS.

What are the terms of MNOV's Standby Equity Purchase Agreement?

The SEPA allows MediciNova to sell common stock over 36 months at 97% of market price, with individual transactions up to 100% of the 5-day trading volume.

What clinical trials is MediciNova currently conducting?

MediciNova is conducting the COMBAT-ALS Phase 2b/3 trial of MN-166, an ALS Expanded Access Program, and a Phase 2 trial of MN-001 for hypertriglyceridemia and fatty liver disease.